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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cranial electrotherapy stimulator to treat insomnia and/or anxiety
510(k) Number K070412
Device Name ELEXOMA MEDIC
Applicant
REDPLANE AG
BAARERSTRASSE 8
ZUG,  CH 6300
Applicant Contact JAEN LABUSCHAGNE
Correspondent
REDPLANE AG
BAARERSTRASSE 8
ZUG,  CH 6300
Correspondent Contact JAEN LABUSCHAGNE
Regulation Number882.5800
Classification Product Code
QJQ  
Subsequent Product Code
GZJ  
Date Received02/12/2007
Decision Date 05/21/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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